Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aeroceuticals — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
56 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K770217 | LANCE LTD. STERI. STITCH CUTTER BLADE | Aeroceuticals | 1977-03-30 | 56 | 0 |
| K760361 | BLADE, SURGICAL SCALPEL, STERILE | Aeroceuticals | 1976-09-13 | 42 | 0 |
| K760363 | SCALPEL, SURGICAL, STERILE STAINLESS | Aeroceuticals | 1976-09-13 | 42 | 0 |
| K760364 | HANDLE, SCALPEL, STAINLESS STEEL | Aeroceuticals | 1976-09-13 | 42 | 0 |
| K760362 | LANCET, BLOOD, STERILE STAINLESS STEEL | Aeroceuticals | 1976-09-13 | 42 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda